Asundexian Phase III Trial Critical for Bayer to Become Market Leader in Anticoagulation to Prevent Stroke in AF Patients

Following the enrollment of the first patient in Bayer’s Phase III OCEANIC-AF clinical trial of asundexian, a potential anticoagulant for stroke prevention in atrial fibrillation (AF) patients;

Amy Murray, Analyst at GlobalData, a leading data and analytics company, offers her view:

“Despite advances in anticoagulation therapy over the last decade, the increased risk and fear of bleeding associated with these drugs significantly contributes to their underuse and low adherence rates in AF patients, as well as to inappropriate use of low-dose anticoagulant regimens. This leaves a widening unmet need for novel anticoagulant therapies that effectively prevent the formation of pathologic thrombi while minimizing bleeding risk in AF patients.

“Factor XIa (FXIa) inhibition offers an attractive strategy to accomplish this as it reduces the formation of pathologic thrombi, while preserving the ability to form clots in response to bleeding. This contrasts with the current standard of care which inhibits factor Xa and consequently reduces the body’s ability to form clots.

“Asundexian is an oral inhibitor of Factor XIa that Bayer is developing as a potential treatment for prevention of stroke in atrial fibrillation, as well as for secondary prevention in patients with a non-cardioembolic ischemic stroke asundexian or high-risk ischemic attack.

“Asundexian was previously studied in the PACIFIC-AF Phase II clinical trial, which compared the safety of asundexian to Eliquis (apixaban), in patients with AF at increased risk for stroke. It was found that participants who received apixaban experienced severe bleeding that was three times higher than those receiving asundexian, supporting the theory that inhibition of FXIa preserves a patient's ability to clot in response to bleeding events.

“Following these encouraging findings, Bayer is now pressing ahead with its Phase III trial, OCEANIC-AF, which is designed to assess the safety, efficacy, and net clinical benefit associated with asundexian versus apixaban in a larger patient population over several years.

“The OCEANIC-AF trial could be critical for Bayer, especially as the patents of blockbuster anticoagulants, Eliquis and Xarelto, will expire later this decade, paving the way for asundexian to become a potential market leader in the future.”

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